India is fast becoming one of the
biggest hubs for conducting global clinical trials. In 2007,
the country conducted around 220 clinical trials, making up
for less than 2 percent of the global clinical trials. But,
according to a new research report, a number of factors such
as low cost, large patient pool, easy recruitment, strong
government support and strengthening of its intellectual
property environment will enable India to conduct nearly 5
percent of the global clinical trials by 2012. The industry
will spend 1500 crore plus on clinical trials in India, as
per Goldman Sachs, Centre watch, Goldman Sachs and McKinsey.

What has led to this dramatic shift in the location of
clinical trials? The change was made in response to
vociferous demands from multinational drug companies and
private organizations that conduct clinical research for a
relaxation of the rules for drug trials — those necessary
hurdles whose price tags can run to 40 percent of the cost
of drug development. It has become increasingly difficult to
test drugs in Western countries, with their strict
regulations, elaborate safety and compensation requirements,
and small populations, all of which make the recruitment of
research subjects slow and expensive.

India is a particularly attractive site for such trials
because of its genetically diverse population of more than 1
billion people with patient pollution suffering from
infectious diseases to chronic illnesses. As most of the
healthcare costs in India are paid 'out of pocket', a large
patient population continues to have unmet medical needs. As
a result, they may readily volunteer to participate in
clinical trials to get free treatment. Virtually all Indian
doctors speak English, and may have acquired postgraduate
qualifications abroad, primarily in Britain or the United
States. Added to these attractions are cheap labor and low
infrastructure costs, which can reduce expenditures for
clinical trials by as much as 60 percent. We, as clinicians,
are interested in bringing more clinical trials to India as,
study of pharmacogenomics gives evidence that drug response
and adverse effects are based on one’s genes.

In January 2005, the government of India enacted a new rule
that allows foreign pharmaceutical companies and other
interested parties to conduct trials of new drugs in India
at the same time that trials of the same phase are being
conducted in other countries. This new rule supersedes a
directive of India's Drugs and Cosmetics Rules that required
a "phase lag" between India and the rest of the world.
According to the old rule, if a phase 3 study had been
completed elsewhere, only a phase 2 study was permitted in
India. Even under the new rule, phase 1 trials will not
normally be permitted in India. The old rule was designed to
protect Indians from being used as guinea pigs in the
testing of unproved drugs of foreign origin; trials of
domestically discovered drugs were not subject to this
provision.

Despite the availability of infrastructure and demand in
India, the area of Clinical Research (CR) is still in its
infancy here. The country has more than half a million
practicing doctors, but fewer than 200 investigators have
been trained in good clinical practice in regards to CR.
Among some 14,000 general hospitals, no more than 150 have
the adequate infrastructure to conduct trials, and there are
fewer than a dozen pathology laboratories that meet the
criteria for compliance with good laboratory practice. Only
about half of the large hospitals have institutional review
boards, and even these boards have not yet formulated
standard operating procedures — and they, too, often lack
the expertise with which to evaluate protocols. Information
about conflicts of interest is neither sought nor
voluntarily provided by investigators. Furthermore, the
Drugs Controller General of India (DCGI) — the equivalent of
the U.S. Food and Drug Administration (FDA) — is
understaffed and lacks the expertise to evaluate protocols.

In 2001, self-styled researchers working in their own
clinics formulated "vaginal pellets" of erythromycin and
tried them as contraceptive agents in more than 790 poor,
illiterate, rural women in West Bengal. In 2003, letrozole,
an anticancer drug, was tested in more than 430 young women
at a dozen private clinics to find out whether it promoted
ovulation. All these trials took place without regulatory
approval. Adverse coverage in the media, that trials in
India are illegal and unethical trials, could mean a loss of
opportunity for India to make a mark on the CR industry.

This calls for the development of its capacities and
capabilities in terms of infrastructure, regulatory
structure, and formulation of specialized pool of research
investigators. The aim by Indian Council of Medical Research
is to generate such professionals who can represent India in
good light, which attracts further international
collaborations. Also, this will help to organize this sector
in a well-defined mould, whose interests will have to be
catered at both local and international level. This will go
a long way in launching and boosting India as a major player
in this area of research and ensure that it does not lag
behind for want of trained manpower.

Currently, per clinicaltrials.org a central registry for all
clinical trials, there are 2208 clinical trials in
Gynecology and 128 trials in Obstetrics, with 7 being done
in India. There are over 31 pregnancy registries with
minimal inputs from obstetricians from India. While we as
Investigators in developing countries could benefit from
rigorous training in the design, conduct, and ethical
oversight of trials, which would allow us to engage more
fully in multinational clinical research at a leadership
level, pressures at work and time constraints may limit us
from attending professional courses.
In following few months I wish to share some topics which
could help some reader’s take active part in this
interesting field. The topics I have in mind are starting
with some common terminologies used in clinical research,
responsibilities of an Investigator, training of staff, FDA
rules pertaining to an investigator, registering a trial,
ethical review committees and any other topic requested by
reader’s.